Pérez Roldán F, De Diego A, Casado M, Matilla A, Bañares R, García-Durán F, Salcedo M, Cos E, Clemente G
Servicio de Aparato Digestivo, Hospital General Universitario, Gregorio Marañón, Madrid.
Rev Esp Enferm Dig. 1996 Sep;88(9):609-15.
The treatment of chronic hepatitis C is interferon (IFN). Diverse predictive factors influence a complete response. The aim of this study was to determine the response to IFN-alpha therapy and factors that may predict a sustained response before and after the first month of treatment. Likewise, it evaluates the relapse and liver cirrhosis evolution after therapy.
We have treated 155 consecutively patients with chronic hepatitis C. Nine left therapy because of severe side effects. We studied the patients who had had persistently elevated serum aminotransferase concentrations, HBsAg negative, HIV negative and antiHCV positive with polymerase chain reaction confirmation, and without any other liver disease. The schedule of IFN-alpha 2b therapy was 5 MU three times per week for 3 months, and later, 3 MU three times per week for 6 more months. There were two groups of response: A) Complete response, if serum aminotransferase levels were normal and RNA-HCV negative, B) No response, if it didn't meet these conditions. The sustained response was complete response during follow-up. The relapse described as aminotransferase increase after suppression therapy with or without positive RNA-HCV, or positive RNA-HCV only.
A complete response was obtained in 34.9%. Ten variables were statistically significant (p < 0.05) on univariate analysis: weight, corporal surface, dosage IFN/m2, bilirubin and total protein pretreatment; polymorphonuclears/mononuclears cells, AST, ALT, AST/ALT, and gamma GT in the first therapy's month. In multivariate analysis, serum AST levels < 40 U/l (odds ratio 0.15, 95% CI 0.04-0.52), and AST/ALT ratio > 0.75 (odds ratio 3.05, 95% CI 1.04-8.9) in the first month, were correlated independently with complete response. Incidence of relapse was 47% of responders, with mean appearance period a of 2.7 +/- 2.1 months. Therefore, a sustained response was obtained in 27 patients (18.5%). Seventeen of 115 patients (14.6%) without cirrhosis initially, developed liver cirrhosis after a second biopsy. Two variables were statistically significant in multiple regression analysis: RNA-HCV positive after treatment (odds ratio 2.99, 95% CI 0.9-2.99), and platelet count < 180,000/mm3 before therapy (odds ratio 17.7, 95% CI 3.7-83.2) were correlated independently with cirrhosis development.
A 9 months course of IFN therapy is effective in a third of patients, but almost half of them have relapsed within 6 months after treatment's suppression. The AST levels and AST/ALT ratio in the first of month therapy were correlated independently with complete response. Liver cirrhosis appears in a small percentage. Platelet count before therapy and RNA-HCV positive at the end treatment, were predictor variables of this evolution.
慢性丙型肝炎的治疗药物是干扰素（IFN）。多种预测因素会影响完全缓解。本研究的目的是确定α干扰素治疗的反应以及在治疗第一个月前后可能预测持续缓解的因素。同样，它评估治疗后的复发情况和肝硬化进展。
我们连续治疗了155例慢性丙型肝炎患者。9例因严重副作用退出治疗。我们研究了血清氨基转移酶浓度持续升高、HBsAg阴性、HIV阴性且经聚合酶链反应确认抗HCV阳性且无任何其他肝病的患者。α干扰素2b治疗方案为每周3次，每次5 MU，共3个月，之后每周3次，每次3 MU，再持续6个月。有两组反应：A）完全缓解，即血清氨基转移酶水平正常且RNA - HCV阴性；B）无反应，即未达到这些条件。持续缓解是指随访期间的完全缓解。复发定义为抑制治疗后氨基转移酶升高，无论RNA - HCV是否阳性，或仅RNA - HCV阳性。
34.9%的患者获得了完全缓解。单因素分析中有10个变量具有统计学意义（p < 0.05）：体重、体表面积、IFN/m²剂量、治疗前胆红素和总蛋白；第一个治疗月的多形核细胞/单核细胞、AST、ALT、AST/ALT和γ - GT。多因素分析中，第一个月血清AST水平<40 U/l（比值比0.15，95%可信区间0.04 - 0.52）以及AST/ALT比值>0.75（比值比3.05，95%可信区间1.04 - 8.9）与完全缓解独立相关。复发率为缓解者的47%，平均出现时间为2.7±2.1个月。因此，27例患者（18.5%）获得了持续缓解。115例最初无肝硬化的患者中有17例（14.6%）在第二次活检后发展为肝硬化。多因素回归分析中有两个变量具有统计学意义：治疗后RNA - HCV阳性（比值比2.99，95%可信区间0.9 - 2.99）以及治疗前血小板计数<180,000/mm³（比值比17.7，95%可信区间3.7 - 83.2）与肝硬化发展独立相关。
9个月的干扰素治疗疗程对三分之一的患者有效，但几乎一半的患者在治疗抑制后6个月内复发。第一个月治疗时的AST水平和AST/ALT比值与完全缓解独立相关。肝硬化发生率较低。治疗前血小板计数和治疗结束时RNA - HCV阳性是这种进展的预测变量。
